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Quality Management System (QMS) Software Market Surges to $20.43 billion at a CAGR 11.7% by 2031 | Report by MarketsandMarkets™

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VEEV Veeva Systems is listed as a top company in the QMS software market, which is experiencing significant growth driven by digitalization and AI adoption. The company is well-positioned to benefit from these trends. HON Honeywell is identified as a key player in the growing QMS software market. The company's involvement suggests it will benefit from the increasing demand for quality management solutions across various regulated industries. MC MasterControl is named among the top companies in the QMS software market. The article highlights the market's growth, driven by digital transformation and AI, indicating a positive outlook for MasterControl. PTC PTC is listed as a leading company in the QMS software market. The article's projection of strong market growth, fueled by AI and cloud adoption, suggests a positive environment for PTC's QMS offerings. ORCL Oracle is recognized as a top company in the QMS software market. The article's emphasis on cloud-native platforms and AI integration indicates a favorable market trend that Oracle is positioned to capitalize on. IBM IBM's expansion of watsonx AI solutions for enterprise deployment is highlighted as a key development supporting AI-driven analytics in regulated industries, aligning with the growth trends in the QMS software market.

Quality Management System (QMS) Software Market Surges to $20.43 billion at a CAGR 11.7% by 2031 | Report by MarketsandMarkets™ Delray Beach, FL, Sept. 18, 2026 (GLOBE NEWSWIRE) -- According to MarketsandMarkets™, the global Quality Management System (QMS) Software Market is projected to grow from USD 11.73 billion in 2026 to USD 20.43 billion by 2031, registering a CAGR of 11.7% during the forecast period.

The market is gaining momentum as manufacturers, life sciences companies, healthcare providers, food & beverage producers, and other regulated organizations digitize quality and compliance processes. Businesses are moving away from paper-based and legacy systems toward centralized, cloud-native platforms that provide real-time quality visibility and connected workflows. Rising regulatory scrutiny, expanding digital transformation programs, and growing demand for analytics are strengthening adoption. QMS platforms are increasingly being used for document control, CAPA, audit management, supplier quality, change control, risk management, and regulatory compliance.

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Key Market Highlights

Why This Market Matters

Quality management is moving from a compliance-focused function toward a strategic business capability. Organizations increasingly need to identify quality risks earlier, maintain regulatory traceability, and make decisions using real-time operational data. Digital QMS platforms can connect quality processes across manufacturing, suppliers, documentation, audits, and corrective actions. This connectivity can reduce fragmented workflows while improving visibility into quality performance.

For regulated industries, the shift also has direct compliance implications. Automated controls, electronic records, and centralized documentation can strengthen audit readiness while supporting increasingly complex regulatory requirements.

Market Overview

The QMS software market provides solutions for quality, compliance, risk, and operational management, including quality analytics & intelligence, CAPA, supplier quality, DCM, audit, and change control. Rising data volumes and the replacement of legacy systems are driving demand for integrated, cloud-native platforms that deliver real-time quality insights and connect with ERP, MES, and PLM systems.

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Analyst Perspective

The QMS software market is entering a phase in which analytics and intelligence are becoming as important as basic compliance functionality. Organizations are seeking platforms that not only record quality events but also identify emerging risks and support proactive intervention. This is increasing interest in predictive analytics, machine learning, AI-assisted workflows, and automated quality insights.

Cloud deployment is reinforcing this transition by providing organizations with scalable infrastructure, faster updates, and broader access to quality information. The combination of cloud infrastructure and AI capabilities is likely to remain a key area of innovation as enterprises pursue more connected quality operations. For technology providers, differentiation will increasingly depend on their ability to combine compliance, analytics, automation, interoperability, and secure AI capabilities within a unified quality environment.

Segment Analysis

Quality Analytics & Intelligence to Register Highest CAGR

By solution type, quality analytics & intelligence is expected to record the highest CAGR during the forecast period. Organizations are generating growing amounts of quality data across audits, CAPAs, complaints, supplier operations, inspections, manufacturing, and regulatory activities. Advanced analytics platforms help convert this information into insights on quality performance, anomalies, risks, and emerging trends.

The market is also shifting from descriptive reporting toward predictive and prescriptive intelligence. AI copilots, natural-language querying, automated insights, digital quality twins, and predictive risk analytics are expanding the capabilities of modern QMS platforms. In June 2025, IBM expanded enterprise deployment capabilities for watsonx AI solutions, supporting large-scale AI-driven analytics and operational intelligence initiatives across regulated industries. Such developments highlight the broader movement toward intelligent quality management.

Cloud-Based Deployment to Hold Largest Market Share

The cloud-based segment is expected to hold the largest market share, driven by growing adoption across life sciences, manufacturing, healthcare, food & beverage, and aerospace. Scalability, real-time data access, lower infrastructure requirements, and seamless updates are accelerating the shift from on-premises QMS platforms, while demand for AI analytics and integration with ERP, MES, and PLM systems is expected to sustain growth.

Regional Analysis

North America is expected to lead the QMS software market, driven by stringent regulatory requirements, advanced manufacturing, and digital transformation across regulated industries. Growing adoption of cloud-based, AI-powered, and integrated quality platforms, along with the FDA’s QMSR, is strengthening demand for compliance, traceability, CAPA management, and audit readiness.

Key Industry Trends

Competitive Landscape

The Top Companies in Quality Management System (QMS) software Market include Hexagon (ETQ) (Sweden), Veeva Systems (US), Siemens (Germany), Honeywell (US), MasterControl (US), PTC (US), SAP (Germany), Oracle (US), Ideagen (US), QAD (US), ComplianceQuest (US), Cority (Canada), SoftExpert (US), Greenlight Guru (US), Fabasoft (Austria), AmpleLogic (India), Ennov (US), Qualio (US), ZenQMS (US), and Omnex (US).

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